A trial of afatinib for people with non small cell lung cancer who cannot have chemotherapy (TIMELY)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Lung cancer

Non small cell lung cancer

Status:

Closed

Phase:

Phase 2

This trial is looking at afatinib (also known as BIBW 2992) for non small lung cancer (NSCLC) in people who cannot have chemotherapy. The trial is supported by Cancer Research UK.

Doctors often treat non small cell lung cancer with chemotherapy. But some people are not well enough to have chemotherapy, or they choose not to have this type of treatment. In this trial, researchers are looking at a drug called afatinib to see if it helps people in this situation.

Afatinib is a type of biological therapy. It works by targeting a protein called epidermal growth factor receptor (EGFR).

Drugs that target EGFR are more likely to work if the cancer cells have a change (mutation Open a glossary item ) to a gene called EGFR.

Lung cancer is often linked to smoking, but people with lung cancer who have never smoked or were light smokers in the past, are more likely to have cancer with an EGFR gene change.

The aim of the study is to see if afatinib helps to stop the growth of non small cell lung cancer in people who have (or are suspected to have) a change to the EGFR gene change.

Who can enter

You may be able to enter this trial if you

Have a non small cell lung cancer (NSCLC) and can’t have treatment aiming to cure your cancer (radical treatment)
Are not well enough to have chemotherapy, or have chosen not to have it
Have cancer that can be measured on a scan
Have satisfactory blood test results
Are at least 18 years old
Are willing to use reliable contraception during the trial and for 4 weeks afterwards if there is any chance you or your partner could become pregnant

To take part in this trial, you must have a change (a mutation) to the EGFR gene, or your doctor suspects you have a change to the gene but there isn’t a suitable sample of your cancer available to test for this, or a sample was looked at but it wasn’t possible to see if there was a change, or this type of testing is not currently available for you.

If it is suspected that you have a change to the EGFR gene, you must

Have a type of NSCLC called adenocarcinoma
Never have smoked, or you stopped smoking more than a year ago and were only a light smoker before that or you didn’t smoke for very long (the trial team can advise you about this)

If it is confirmed that you have a change to the EGFR gene, you can be a smoker and have any type of NSCLC.

As well as the above, if you have a change to the EGFR gene, you must be well enough to be up and about for at least some of each day, even if you need help looking after yourself (performance status 0, 1, 2 or 3). If it suspected that you have the gene change, you must be well enough to be up and about for at least half the day (performance status 0, 1 or 2).

You cannot enter this trial if you

Have cancer that has spread to your brain unless this has been treated, has not got worse for at least 4 weeks, you don’t take drugs to prevent fits and if you take steroids, have been having the same dose for at least a month
Have already had chemotherapy for NSCLC that has come back or spread to another part of your body (you may be able to take part if you had chemotherapy before or after surgery to try to stop your cancer coming back as long as this was at least a year ago)
Have already had afatinib or a similar drug
Have had surgery in the last 4 weeks
Have had radiotherapy in the last 2 weeks (or earlier if it was palliative radiotherapy to a single area of cancer)
Have had another experimental drug in the last 8 weeks
Are having any other anti cancer treatment
Cannot swallow or absorb drugs that you take by mouth, or have problems with your digestive system such as diarrhoea
Have a lung condition called interstitial lung disease
Have had any other type of cancer in the last 5 years apart from non melanoma skin cancer or carcinoma in situ of the cervix
Have had a heart attack in the last 6 months or have certain other heart problems - the trial doctors can advise you about this
Have an infection or any other medical condition that the trial doctors think could affect you taking part
Are known to be HIV positive or have hepatitis
Use alcohol or drugs in a way that is a cause for concern
Are known to be allergic to afatinib or anything in it
Are pregnant or breastfeeding

Trial design

This phase 2 trial will recruit 37 people. Everybody taking part has afatinib.

You take afatinib tablets every day an hour before eating or at least 3 hours after a meal. You keep a diary at home to note down when you take your tablets, any side effects you have and how much water you drink each day.

As long as you don’t have bad side effects, you can carry on taking afatinib for as long as it helps you.

If your cancer gets worse and you stop taking afatinib, the trial team will ask to take a sample of your cancer (a biopsy Open a glossary item ). This is to learn more about the type of cancer you have and how the drug affects it.

Hospital visits

You see the trial doctors and have some tests before you start the trial treatment. The tests include

Physical examination
Chest X-ray
CT scan
Blood tests
Urine test
Heart trace (ECG )

You will have a bone scan if your doctor thinks your cancer may have spread to your bones.

You go to hospital

Every 2 weeks for the first 8 weeks
Once a month for the rest of the 1st year of treatment
Every 2 months after that

You have a physical examination and blood tests at each visit. You may have an ECG. You have a CT scan after 4 weeks of treatment and then every 2 months for a year. If you carry on taking afatinib for longer than a year, you then have a CT scan every 3 months.

When you finish treatment, you see the trial team every 2 months until a year has passed since you started treatment, and then every 3 months after that.

Side effects

As afatinib is still quite a new drug, there may be side effects we don’t know about yet. The known side effects include

Diarrhoea
Skin reactions such as a rash or dry skin
Sore mouth
Nail changes
Tiredness (fatigue)
Nosebleeds
Feeling or being sick
Cough
Eye problems (you must tell the trial team if you get red, dry or watery eyes, blurred vision, irritation or eye pain)
Swelling (inflammation) of your lungs (you must tell the trial team if you begin to feel breathless)

Recruitment start:

01/03/2013

Recruitment end:

13/08/2015

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

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Questions to ask your doctor about clinical trials

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Sanjay Popat

Supported by

Boehringer Ingelheim
Cancer Research UK
Experimental Cancer Medicine Centre (ECMC)
NIHR Clinical Research Network: Cancer
University College London (UCL)